Drug recall D-1576-2020

Class I Terminated reported Sep 9, 2020

Product

Tranexamic Acid Injection, USP, 1000 mg/10 mL (100 mg/mL), 10 mL Single-Dose Vial (NDC 67457-197-00); 10 x 10 mL Single-Dose Vials per carton (NDC 67457-197-10), Rx only, Manufactured by: Mylan Institutional, Galway, Ireland; Manufactured for: Mylan Institutional LLC, Rockford, IL 61103.

Reason for recall

Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP.

Lots and codes

Lot #: 191207, 191221, 191223, Exp. 11/2021; 200120 Exp. 12/2021

Recall details

Recalling firm
Mylan Institutional LLC, Rockford, IL
Quantity
1407 cartons
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
August 17, 2020
Terminated
December 28, 2022

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